MSAT Principal Scientist, Conjugation

Summary:

The successful candidate is part of a team of highly skilled Scientists and Engineers responsible for technical and scientific support to manufacturing of all Seagen products, whether manufactured internally or at contract manufacturing organizations (CMO’s) across the world. You will provide technical and scientific leadership as subject matter expert (SME) relating to conjugation manufacturing processes. The person will be responsible for leading improvements to technical transfer processes and driving conjugation manufacturing continuous improvement projects. You will also partner closely with other cross-functional leaders in Manufacturing, Process Development, Quality, and Supply Chain to ensure manufacturing projects stay on-track.

Responsibilities:

• Responsible for conjugation manufacturing support for clinical and commercial biologics including routine monitoring/trending
• Providing guidance for root cause investigations of process related deviations in a timely, comprehensive, and conclusive manner
• Acts as Tech Transfer lead for transfer of processes into manufacturing facilities
• Responsible for development of process documentation (Master batch records, protocols, change controls, standard operating procedures and other cGMP documentation)
• Identify and drive technical innovations that will contribute to future business developments and improvements
• Collaborate with the global MSAT team to create and foster a scientific climate of excellence to achieve business goals
• Leads the data analysis of process data statistics, identifies process deviations, assesses product impact, prepares technical reports and proposes process solutions and improvements
• Acting as person-in-plant during tech transfer, validation studies and manufacturing
• Interfacing with Development and manufacturing sites for know-how transfers and process data analysis & mapping in order to anticipate potential risks and opportunities for improvements supporting next generation manufacturing processes. Identifies and initiates process and procedural changes to improve process performance, robustness, productivity, safety, efficiency and compliance
• Partnering with other functions to apply modeling tools ensuring that scale-down/up and characterization of manufacturing processes is robust and scientifically sound leading to a predictable and highly consistent performance and a well characterized process
• Providing guidance for comprehensive facility fit assessments and gap analysis for GMP manufacturing
• Lead authorship of CMC regulatory submissions and responses May function as a process SME during inspections and interactions with regulatory agencies
• Supervise and mentor research associates, specialists and/or scientists
• Interact with cross-functional groups (e.g. Process Sciences
• Manufacturing, Quality, and Regulatory)

Qualifications:

• Outstanding record of accomplishment in areas of conjugation development, improvement, scale-up, transfer and validation
• Experience with tangential flow filtration, virus retentive filtration, column chromatography
• Knowledge of protein chemistry and analytical techniques (SEC-HPLC, RP-HPLC, HIC-HPLC)
• Strong scientific and technical experience within relevant development and/or manufacturing technologies and unit operations. Preferably experience with equipment utilized in commercial cGMP manufacturing facilities
• Good knowledge of structured methodologies for process design, scale-up/down models, process control strategies, process validation and continuous process verification
• The ability to work effectively in small matrix teams in a fast-paced environment with changing priorities and a high level of urgency
• Highly motivated with the ability to work independently as well as on cross-functional and cross-site teams
• Able to effectively establish and maintain productive relationships with senior technical staff within and outside of Seagen
• Demonstrated skills of independent thought and creativity in science and engineering
• The candidate must demonstrate high levels of integrity. Key competencies are management of complexity, driving for results, problem-solving and collaborating cross-functionally
• Strong communication skills and computer literacy are essential
• Experience with innovation and operational excellence is desirable
• A good understanding of statistical analysis and continuous process verification is required

Education

• B.S., M.S., or Ph.D. in chemical engineering, biology, or another relevant life-science discipline
• PhD degree with 6+ years of industrial experience; B.S. or M.S. with commensurate amount of industrial experience

As the leading employer in our industry in the Pacific Northwest, Seagen is proud to offer a competitive total compensation package as well as a comprehensive benefits program designed to support the whole lives of our employees and their families. Benefits include medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more. To learn more about Seagen, please visit www.seagen.com.

Seagen is an equal opportunity employer. All qualified applications will receive consideration for employment without regard to race, age, gender identity, sexual orientation, color, religion, sex, marital status, national origin, protected veteran status, disability status, or any other status protected by federal, state, or local law.

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